The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)

NCT03862417 | Recruiting

• 1 other identifier: Pro00086262
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Adult degenerative scoliosis is the most common spine deformity in adults. Patients present a lateral curvature of the spine and vertebra rotation. Curves meeting indications for treatment affect 24% of the aging adult population. Adult scoliosis causes pain, curve progression, and cosmetic deformity affecting quality of life and function. Pain affects 90% of patients with AS. Other than surgery for severe cases and pain medication, very little non-operative treatments have been investigated. Scoliosis-specific exercises have shown promise in a single study in adults and in an Alberta adolescent study. The goal of this pilot randomized controlled trial on the effect of Schroth exercises in adults with degenerative scoliosis compared to observation is to determine the feasibility of conducting a larger study. This study will help plan and secure funding for a larger study by examining the ability to recruit enough eligible participants, whether patients can follow the prescribed program session attendance and complete the home exercises prescribed. The early estimate the effects of the exercises on pain, quality of life, disability, deformity and posture measurements will help determine the potential of this approach and the likely success of a larger RCT. This study addresses a need of adults with degenerative scoliosis who do not meet surgical indications but still experience pain and disability by exploring a promising exercise approach.

Conditions

Degenerative Scoliosis

Keywords

Scoliosis; Exercise; Pain; Posture; Quality of life; Disability

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  Percent of patients enrolled out of all patients invited.

  1 year

Secondary Outcomes (4)

• Eligibility rate

  1 year

• Compliance

  1 year

• Adherence

  1 year

• Drop out rate

  1 year

Other Outcomes (14)

• Pain intensity assessed bhy the

  3 months, 6 months in Schroth group, 3 months, 6 months, 9 months in Control group

• Pain location

  3 months, 6 months in Schroth group, 3 months, 6 months, 9 months in Control group

• Scoliosis Research Society 22r scores

  3 months, 6 months in Schroth group, 3 months, 6 months, 9 months in Control group

Study Arms (2)

Schroth exercise group

EXPERIMENTAL

Will attend 5 1-hr long individual sessions to learn Schroth exercises and the home program. A 30-min. daily home program of 3 to 4 exercises will be progressed by the certified Schroth therapist using an algorithm. Patients will attend weekly 1-hr long group therapist-led exercise classes for 3 months. At each group class, adequate exercise performance will be assessed using the checklist. An algorithm guides the prescription of exercises intensity and progression from static to dynamic depending on the participant's ability. Prescription begins with Sitting on a Ball. If performed adequately, a more challenging exercise is attempted. The 3 most challenging exercises performed adequately as per the checklist will be prescribed with a detailed handout.

Other: Schroth exercises

Control group

NO INTERVENTION

Observation without treatment or with previously prescribed pain medication is the current standard for adults with degenerative scoliosis not planning surgery.

Interventions

Schroth exercises OTHER

An exercise program begun individually and then continued in groups.

Also known as: Schroth

Schroth exercise group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Curves over 50° are surgical candidates, and will be excluded. Patients who have had cortisone or anesthetic injections within the last 3 months, surgery or presenting contra-indications to exercises (fractures, cancer, severe cardio-vascular co-morbidities, or osteopenia) will be excluded.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy

Edmonton, Alberta, T6G2G4, Canada

RECRUITING

MeSH Terms

Conditions

Scoliosis; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Parent, PT PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Parent, PhD

CONTACT

7804928889; eparent@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Baseline exams will occur before randomization. Participants and therapists will be reminded not to discuss their group allocation. Evaluators will be blinded to group allocation. The statistician will also complete analyses blinded to which group received therapy or when they did.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the observation (control) group or the Schroth exercise treatment group using REDCAP. All outcomes will be measured at baseline and at a 3-month follow-up. Longer term effects will be assessed 3 months after the exercise program. The control group will be under observation for 3 months. The Schroth group will participate in weekly supervised sessions and a daily home program for 3 months. After 3 months, controls will undergo the same exercise protocol. This will allow examining exercise effects using these patients as their own controls and improve willingness for randomization.

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 5, 2019
• Study Start: September 1, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)